Quantib Prostate 1.1
by Quantib B.V.
Quantib Prostate 1.1 is a Class II device made by Quantib B.V., cleared under FDA 510(k) K202501 on 11 Oct 2020, registered in EUDAMED and listed in FDA GUDID since 4 Dec 2020 (UDI-DI 08719689791117), active as of 23 Oct 2026.
Active
CE MDR 510(k)
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number08719689791117 | Date4 Dec 2020 | StatusListed |
| United States | FDA 510(k) GUDID | NumberK202501 | Date11 Oct 2020 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Official records
- EUDAMED public site
- AccessGUDID record 08719689791117
- FDA 510(k) database K202501
Across registries
- FDA 510(k) K202501 decided 11 Oct 2020 Active
- EUDAMED Active
- FDA GUDID UDI-DI 08719689791117 listed 4 Dec 2020 Listed
Timeline
- Cleared FDA 510(k) K202501
- Listed FDA GUDID 08719689791117
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Quantib Prostate
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 1.1
- Primary DI / UDI-DI
- 08719689791117
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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